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Indirect Treatment Comparison: Placebo-Adjusted Results From Phase 3 Trials of Two GC-C Agonists in Patients with Chronic Idiopathic Constipation - Linaclotide and Plecanatide

Phillip Schoenfeld,An-Chen Fu, Courtney E. Walls,David S. Reasner, Kenneth J. Tripp,Robyn T. Carson,Jessica Abel,Douglas C. A. Taylor

GASTROENTEROLOGY(2017)

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Abstract
CTT and HRAM test were enrolled in this study.The diagnostic yield of BET, as well as CTT compared with HRAM was determined, and agreement between BET, as well as CTT and HRAM data was evaluated.RESULTS: Of the constipated patients, 269(70.8%)were diagnosed with dyssynergia using HRAM.Among the 269 patients with dyssynergia, type I dyssynergia was most common (n =143, 53.2%), followed by type III (n =75, 27.9%), type II ( n =27, 10%), and type IV (n =24, 8.9%).The sensitivity, specificity, and positive predictive value (PPV) of BET in the diagnosis of dyssynergia were 85.3%, 71.1%, 77.0%, respectively, and moderate agreement was seen between the two modalities (κ -coefficient = 0.409, P <0.001).The diagnostic sensitivity (92.5%) of BET was more higher in type I DD group compared with the other three subtypes.The specificity and PPV were 68.3% and 86.7%, respectively.The sensitivity, specificity, and PPV of CTT in the diagnosis of dyssynergia were 62.8%, 80.2%, 71.5%, respectively.However, there was poor agreement for anal resting tone (κ -coefficient =0.083, P =0.208).In all four subgroups, the diagnostic sensitivity (72.8%) of CTT was relatively highest in type I DD group, and the specificity and PPV were 70.3% and 66.7%, respectively.CONCLUSIONS: BET shows high sensitivity and positive predictive value in detecting dyssynergia compared with HRAM, and could therefore be used as a bedside screening test for the diagnosis of this disorder.Further studies are warranted to evaluate the correlation between CTT and HRAM in assessing DD.
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Key words
chronic idiopathic constipation,indirect treatment comparison,linaclotide,placebo-adjusted
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